(266 days)
EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac thythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recorded ECG data can be transferred in an available file on PC via the USB connection.
During wearing, EZYPRO ECG Recorder (Model: UG02) can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals. EZY iSee does not contain diagnostic interpretation.
UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data.
EZYPRO ECG Recorder (Model: UG02) can record cardiac rhythm up to 14 days. Wearing duration is adjustable based on different needs of the physicians.
The recorder is lightweight, wire free, and easy to carry around; Will not interfere patient's daily routine or any activities.
Patient's symptomatic episodes can be marked by proactive pressing the blue button on the recorder; Physicians could later look back at the data and use it in the diagnosis.
EZYPRO ECG Recorder is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis.
The provided text describes the regulatory clearance of the EZYPRO ECG Recorder (Model: UG02) and its substantial equivalence to a predicate device. It details non-clinical testing performed but does not include information about acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) based on clinical data or a study describing how these criteria were met.
The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This means that a study proving the device meets performance-based acceptance criteria (as typically understood in terms of diagnostic accuracy or reader improvement for AI devices) was not conducted or submitted for this 510(k) clearance.
Therefore, many of the requested items cannot be answered from the provided text.
Based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific performance-based acceptance criteria for diagnostic accuracy metrics (e.g., sensitivity, specificity for arrhythmia detection) as no clinical trials were conducted to assess these aspects. The "acceptance criteria" referred to in the document relate to the successful completion of various non-clinical engineering and safety tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Reliability Test | Met requirements |
| Reliability Evaluation (ME) | Met requirements |
| Reliability (500 cycles reusable) | Met requirements |
| Shelf Life Test | Met requirements |
| Biocompatibility | Met requirements |
| In Vitro Cytotoxicity Test (Agar Diffusion) | Met requirements |
| Intracutaneous Irritation Study in Rabbits | Met requirements |
| Skin Sensitization Study in Guinea Pigs (Maximization Test) | Met requirements |
| Software Validation | Met requirements |
| Recorder Firmware Validation | Met requirements |
| EZY iSee Software Validation | Met requirements |
| UG02 Setting Tool Software Validation | Met requirements |
| Cybersecurity Management | Met requirements |
| EMC and Electrical Safety | Met requirements |
| IEC 60601-1 Test | Met requirements |
| EMC Test | Met requirements |
| Radio Spectrum Test | Met requirements |
| SAR Evaluation | Met requirements |
| Safety Requirements for Portable Sealed Secondary Cells | Met requirements |
| Lithium Polymer Battery Safety Test | Met requirements |
| IEC 60601-1-11 Test | Met requirements |
| Energy Reduction Test | Met requirements |
| Medical Electrical Equipment Performance | Met requirements |
| IEC 60601-2-47 Test | Met requirements |
| Product Function Test (EE) | Met requirements |
| Disposable ECG electrodes Test | Met requirements |
| QRS and Heart Rate Accuracy | Met requirements |
| HFE/UE | Met requirements |
| MR Unsafe Evaluation | Met requirements |
| RF Wireless Evaluation | Met requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical test data was used for a test set. The non-clinical tests were performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test data requiring expert review for ground truth was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test data requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is for recording and manual interpretation of ECG; there is no mention of AI assistance or a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device explicitly states: "EZYPRO ECG Recorder is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis." Therefore, a standalone algorithm performance evaluation would not be relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical data requiring ground truth for performance evaluation was used. The "ground truth" for non-clinical tests would be defined according to the specific test standards (e.g., electrical safety standards, biocompatibility standards).
8. The sample size for the training set
Not applicable, as there is no mention of a training set for an algorithm. The device is not intended for automated analysis.
9. How the ground truth for the training set was established
Not applicable.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).